Nano & Chemical Substances
The safety of chemical substances is covered by the REACH legislation (EU Regulation on chemicals and their safe use) which came into force in 2007. This legislation has extensive information obligations for chemicals, particularly on the hazards that they pose to human health and the environment.
Nanomaterials are regulated under REACH because they fall under its definition of a chemical "substance". The general obligations of the legislation therefore apply as for any other substance and there are no provisions referring explicitly to nanomaterials.
Hundreds of products containing nanomaterials are already in use. Examples are batteries, coatings, anti-bacterial clothing etc. Nanomaterials have the potential to improve the quality of life and to contribute to industrial competitiveness in Europe.
However, the new materials may also pose risks to the environment and raise health and safety concerns. These risks, and to what extent they can be tackled by the existing risk assessment measures in the EU, have been subject to several opinions from the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR).
The overall conclusion so far is that, even though nanomaterials are not per se dangerous, there still is scientific uncertainty about the safety of nanomaterials in many aspects and therefore the safety assessment of the substances must be done on a case-by-case basis.
A project on "Scientific technical support on nanomaterials" (RIPoNs) was launched in January 2010 by the Institute for Health and Consumer Protection (IHCP) together with the European Commission (Directorate-General for Environment, Directorate-General for Enterprise and Industry) and the European Chemicals Agency (ECHA). Together they are developing scientific advice on how to fulfil the information requirements for nanomaterials specified under the European chemicals legislation.
The test methods to be used for nanomaterials have been assessed by the Institute and its conclusions have been taken up and published by the OECD (‘Guidance Manual for the Testing of Manufactured Nanomaterials’). This will help ensure that the information collected from testing programmes is reliable, accurate and consistent.
Registration and labelling
The first registration deadline under REACH (30 November 2010) applies to substances manufactured or imported at a level of 1,000 tonnes or more per year. Registrations of nanomaterials in this tonnage band will help to generate more information useful for the assessment of risks. The European Chemicals Agency (ECHA) receives the registrations and the Agency plays a central role in the collection, evaluation and dissemination of information on substances and preparations, including nanomaterials.
Nanomaterials that are classified as hazardous under EU Regulations must be classified and labelled. Many of the related provisions, including safety data sheets and classification and labelling apply already today, independently of the tonnage in which the substances are manufactured or imported. Substances, including nanomaterials, meeting the classification criteria as hazardous must be notified to ECHA by 3 January 2011.